BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET / ZIMMER

    MDR report key: 334301 · Received May 18, 2001

    Report

    Report Number
    334301
    Event Type
    Injury
    Date Received
    May 18, 2001
    Date of Event
    March 29, 2001
    Report Date
    May 17, 2001
    Manufacturer
    BIOMET
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    TIBIAL BEARING COMPONENT WAS NOTED TO BE WORN. ALL COMPONENTS REPLACED, REVISION PERFORMED IN 2001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23469 BIOMET / ZIMMER MAXIMUM PRIMARY TIBIAL BEARING JWH BIOMET * 55093600
    23470 MAXIM PRIMARY FEMORAL COMPONENT 65 MM LEFT / INTERLOK HSA BIOMET * 205330
    23471 MAXIM INTERLOK 63 MM FIXED I-BEAM TIBIAL PLATE WITH LOCKING BAR HSH BIOMET * 181150
    23472 BIOMET ARCUM ALL POLY PAT BUTTON U/X-RAY WIRE/34MM(MEDIUM) 9 MM HEIGHT HTG BIOMET * 590630
    23473 MAXIM PRIMARY TIBIAL BEARING * JWH BIOMET * 588110

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other| R